There are a number of different types of drug delivery devices that are all configured to receive, hold and dispense a dosage of medication. For example, one type of drug delivery device that is commonly used in a medical or pharmaceutical setting is a disposable syringe. Another drug delivery device that is commonly used to administer medication to a patient is an infusion or drug delivery bag. In particular, the drug delivery bag can be an IV (infusion) bag that is a flexible container whose inner cavity is sterile and which is optionally totally or partially filled with a sterile, pyrogen-free fluid intended for infusion into the arteriovenous system of humans or animals. Such bags can be purchased already filled and labeled from a manufacture, or can be purchased empty to be filled with appropriate fluids in a pharmacy. Infusion bags are utilized for intravenous delivery of fluids and medication to human beings or animals. For this reason, the infusion bag is provided with at least one outlet channel (infusion port) through which fluid can flow through an infusion line to a connecting device such as, for example, a cannula/catheter that is inserted through the skin into a vein, such as a peripheral vein and an inlet channel (fill port) through which medication can be injected.
There are a number of different intravenous access methods for delivering the medication to the patient. Fluids contained in the IV bags can be administered continuously or intermittently. When administered intermittently, the fluid can be co-administered through an IV set through which continuous administration of another fluid is already occurring or can be administered through its own arterio-venous access. The process of co-administering an intermittently administered IV fluid with a continuously running IV fluid is called “piggybacking”.
Accordingly, one conventional IV arrangement is for the IV bag to contain an infusion fluid and then either another IV bag or some other structure contains the medication to be delivered. The medication is then delivered in a controlled manner with the infusion fluid to the vein of the patient. This is a labor intensive manual process and requires careful precision in selecting the correct drug and the correct amount that is delivered to the patient. In addition, human touch contamination is the single most common form of dose contamination, and therefore, there is a desire to automate the process so as to minimize or eliminate the opportunity for such contamination by removing the human from the production process.
In a number of different applications automating the medication preparation process would result in increased production and efficiency being achieved. Such automation finds particular utility in settings, such as hospitals, where pharmacies prepare a large number of these doses daily. This would result in reduced production costs and also permits the system to operate over any time period of a given day with only limited operator intervention for manual inspection to ensure proper operation is being achieved. Such automation would find particular utility in settings, such as large hospitals, including a large number of doses of medications that must be prepared daily. Traditionally, these doses have been prepared manually in what is an exacting but tedious responsibility for a highly skilled staff. In order to be valuable, automated systems must maintain the exacting standards set by medical regulatory organizations, while at the same time simplifying the overall process and reducing the time necessary for preparing the medications, and, where practical, eliminating human manipulation and the attendant possibility of touch contamination.
Previous methods of dispersing the medication from a vial and into a drug delivery device, such as a syringe or IV bag, were very time consuming and labor intensive. More specifically, medications and the like are typically stored in a vial that is sealed with a safety cap or the like. In conventional medication preparation, a trained person retrieves the correct vial from a storage cabinet or the like, confirms the contents and then removes the safety cap manually. This is typically done by simply popping the safety cap off with one's hands. Once the safety cap is removed, the trained person inspects the integrity of the membrane and cleans the membrane. An instrument, e.g., a needle, is then used to pierce the membrane and withdraw the medication contained in the vial. The withdrawn medication is then placed into a drug delivery device to permit subsequent administration of the medication from the device. Many drugs cannot maintain adequate shelf life when stored in liquid form and so are provided in powdered form. In this case, the process is even more labor-intensive in that the preparation also involves the injection of a fluid (called the diluent) into the vial to liquefy the drug powder and agitation until the drug is completely liquified prior to aspiration of the resultant fluid from the vial and injecting that fluid into the IV bag. This can be a time consuming and labor intensive operation since first it must be determined how much diluent to add to achieve the desired concentration of medication and then this precise amount needs to be added and then the vial contents need to be mixed for a predetermined time period to ensure that all of the solid goes into solution. Thus, there is room for human error in that the incorrect amount of diluent may be added, thereby producing medication that has a concentration that is higher or lower than it should be. This can potentially place the patient at risk and furthermore, the reconstitution process can be very labor intensive since it can entail preparing a considerable number of drug delivery devices that all can have different medication formulations. This can also lead to confusion and possibly human error.